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1.  Clinical recovery time from conscious sedation for dental outpatients. 
Anesthesia Progress  2002;49(4):124-127.
For dental outpatients undergoing conscious sedation, recovery from sedation must be sufficient to allow safe discharge home, and many researchers have defined "recovery time" as the time until the patient was permitted to return home after the end of dental treatment. But it is frequently observed that patients remain in the clinic after receiving permission to go home. The present study investigated "clinical recovery time," which is defined as the time until discharge from the clinic after a dental procedure. We analyzed data from 61 outpatients who had received dental treatment under conscious sedation at the Hiroshima University Dental Hospital between January 1998 and December 2000 (nitrous oxide-oxygen inhalation sedation [n = 35], intravenous sedation with midazolam [n = 10], intravenous sedation with propofol [n = 16]). We found that the median clinical recovery time was 40 minutes after nitrous oxide-oxygen sedation, 80 minutes after midazolam sedation, and 52 minutes after propofol sedation. The clinical recovery time was about twice as long as the recovery time described in previous studies. In a comparison of the sedation methods, clinical recovery time differed (P = .0008), being longer in the midazolam sedation group than in the nitrous oxide-oxygen sedation group (P = .018). These results suggest the need for changes in treatment planning for dental outpatients undergoing conscious sedation.
PMCID: PMC2007416  PMID: 12779113
2.  Drugs Used for Parenteral Sedation in Dental Practice 
Anesthesia Progress  1988;35(5):199-205.
The relative efficacy and safety of drugs and combinations used clinically in dentistry as premedicants to alleviate patient apprehension are largely unsubstantiated. To evaluate the efficacy and safety of agents used for parenteral sedation through controlled clinical trials, it is first necessary to identify which drugs, doses, and routes of administration are actually used in practice. A survey instrument was developed to characterize the drugs used clinically for anesthesia and sedation by dentists with advanced training in pain control. A random sample of 500 dentists who frequently use anesthesia and sedation in practice was selected from the Fellows of the American Dental Society of Anesthesiology. The first mailing was followed by a second mailing to nonrespondents after 30 days. The respondents report a variety of parenteral sedation techniques in combination with local anesthesia (the response categories are not mutually exclusive): nitrous oxide (64%), intravenous conscious sedation (59%), intravenous “deep” sedation (47%), and outpatient general anesthesia (27%). Drugs most commonly reported for intravenous sedation include diazepam, methohexital, midazolam, and combinations of these drugs with narcotics. A total of 82 distinct drugs and combinations was reported for intravenous sedation and anesthesia. Oral premedication and intramuscular sedation are rarely used by this group. Most general anesthesia reported is done on an outpatient basis in private practice. These results indicate that a wide variety of drugs is employed for parenteral sedation in dental practice, but the most common practice among dentists with advanced training in anesthesia is local anesthesia supplemented with intravenous sedation consisting of a benzodiazepine and an opioid or a barbiturate.
PMCID: PMC2167868  PMID: 3250279
3.  Assessment of the effects of ketamine-fentanyl combination versus propofol-remifentanil combination for sedation during endoscopic retrograde cholangiopancreatography 
Background:
Endoscopic retrograde cholangiopancreatography (ERCP) as a diagnostic and treatment procedure is used in most biliary tract and pancreatic. Either sedation or general anesthesia could be considered for this procedure. Combining a sedative with an opioid agent can provide effective moderate sedation. This study compared the impact of ketamine-fentanyl (KF) versus propofol-remifentanil (PR) on sedation scale in patients undergoing ERCP.
Materials and Methods:
As a double-blinded randomized clinical trial, 80 patients selected by convenient sampling, allocated randomly into two groups. KF group received ketamine 0.5 mg/kg body weight intravenously over 60 s and then fentanyl 1 mcg/kg body weight intravenously. PR group received propofol l mg/kg body weight intravenously over 60 s and then remifentanil 0.05 mcg/kg body weight/min intravenously. Intravenous (IV) infusion of propofol was maintained by 50 mcg/kg body weight/min throughout ERCP. Ramsay Sedation Score, vital signs, oxygen saturation (SpO2), recovery score (modified Aldrete score) and visual analog scales of pain intensity, and endoscopist's satisfaction were considered as measured outcomes. All analysis were analyzed by SPSS Statistics version 22 and using t-test, Chi-square and repeated measured ANOVA and Mann-Whitney tests for data analysis.
Results:
Respiratory rate and SpO2 level during the time intervals were lower in PR group (P < 0.001). Sedation score at intervals was not significantly different (P = 0.07). The frequency of apnea in PR group was significantly higher than the KF group (P = 0.003). The percentage of need to supplemental oxygen in PR group was 35.1% that was also significantly higher than 8.8% in the KF group (P = 0.008), but the dosage frequency was significantly higher in KF group (P < 0.001). The KF and PR groups average length of stay in the recovery room were 50.71 standard deviation (SD = 9.99) and 42.57 (SD = 11.99) minutes, respectively, indicating a significant difference (P = 0.003). The mean severity of nausea in KF and PR groups was, respectively, 2.74 confidence interval (CI = 1.68-3.81) and 0.43 (CI = 0.11-0.75), that was significantly higher in KF group (P < 0.001). The average score of surgeon satisfaction in both KF and PR groups were 7.69 (CI = 7.16-8.21) and 8.65 (CI = 8.25-9.05), respectively, which was higher in KF group (P = 0.004), but the average level of patients satisfaction in KF group was 8.86 (CI = 8.53-9.19) and in PR group was 8.95 (CI - 8.54-9.35) that were not significantly different (P = 0.074).
Conclusion:
There is no statistically significant difference between KF and PR combinations in sedation score, but PR combination provides better pain control, with less nausea and shorter recovery time while causing more respiratory side effects, that is, apnea and need to oxygen.
PMCID: PMC4268195  PMID: 25535501
Endoscopic retrograde cholangiopancreatography; fentanyl; ketamine; propofol; remifentanil
4.  Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study 
BMC Gastroenterology  2012;12:164.
Background
There is increasing interest in balanced propofol sedation (BPS) titrated to moderate sedation (conscious sedation) for endoscopic procedures. However, few controlled studies on BPS targeted to deep sedation for diagnostic endoscopy were found. Alfentanil, a rapid and short-acting synthetic analog of fentanyl, appears to offer clinically significant advantages over fentanyl during outpatient anesthesia.
It is reasonable to hypothesize that low dose of alfentanil used in BPS might also result in more rapid recovery as compared with fentanyl.
Methods
A prospective, randomized and double-blinded clinical trial of alfentanil, midazolam and propofol versus fentanyl, midazolam and propofol in 272 outpatients undergoing diagnostic esophagogastroduodenal endoscopy (EGD) and colonoscopy for health examination were enrolled. Randomization was achieved by using the computer-generated random sequence. Each combination regimen was titrated to deep sedation. The recovery time, patient satisfaction, safety and the efficacy and cost benefit between groups were compared.
Results
260 participants were analyzed, 129 in alfentanil group and 131 in fentanyl group. There is no significant difference in sex, age, body weight, BMI and ASA distribution between two groups. Also, there is no significant difference in recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between two groups. Though deep sedation was targeted, all cardiopulmonary complications were minor and transient (10.8%, 28/260). No serious adverse events including the use of flumazenil, assisted ventilation, permanent injury or death, and temporary or permanent interruption of procedure were found in both groups. However, fentanyl is New Taiwan Dollar (NT$) 103 (approximate US$ 4) cheaper than alfentanil, leading to a significant difference in total cost between two groups.
Conclusions
This randomized, double-blinded clinical trial showed that there is no significant difference in the recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between the two most common sedation regimens for EGD and colonoscopy in our hospital. However, fentanyl is NT$103 (US$ 4) cheaper than alfentanil in each case.
Trial registration
Institutional Review Board of Buddhist Tzu Chi General Hospital (IRB097-18) and Chinese Clinical Trial Registry (ChiCTR-TRC-12002575)
doi:10.1186/1471-230X-12-164
PMCID: PMC3607964  PMID: 23170921
Balanced propofol sedation; Alfentanil; Fentanyl; Deep sedation; Diagnostic endoscopy; Cost benefit
5.  Comparison of Propofol-Remifentanil Versus Propofol-Ketamine Deep Sedation for Third Molar Surgery 
Anesthesia Progress  2012;59(3):107-117.
This study aimed to compare continuous intravenous infusion combinations of propofol-remifentanil and propofol-ketamine for deep sedation for surgical extraction of all 4 third molars. In a prospective, randomized, double-blinded controlled study, participants received 1 of 2 sedative combinations for deep sedation for the surgery. Both groups initially received midazolam 0.03 mg/kg for baseline sedation. The control group then received a combination of propofol-remifentanil in a ratio of 10 mg propofol to 5 μg of remifentanil per milliliter, and the experimental group received a combination of propofol-ketamine in a ratio of 10 mg of propofol to 2.5 mg of ketamine per milliliter; both were given at an initial propofol infusion rate of 100 μg/kg/min. Each group received an induction loading bolus of 500 μg/kg of the assigned propofol combination along with the appropriate continuous infusion combination . Measured outcomes included emergence and recovery times, various sedation parameters, hemodynamic and respiratory stability, patient and surgeon satisfaction, postoperative course, and associated drug costs. Thirty-seven participants were enrolled in the study. Both groups demonstrated similar sedation parameters and hemodynamic and respiratory stability; however, the ketamine group had prolonged emergence (13.6 ± 6.6 versus 7.1 ± 3.7 minutes, P = .0009) and recovery (42.9 ± 18.7 versus 24.7 ± 7.6 minutes, P = .0004) times. The prolonged recovery profile of continuously infused propofol-ketamine may limit its effectiveness as an alternative to propofol-remifentanil for deep sedation for third molar extraction and perhaps other short oral surgical procedures, especially in the ambulatory dental setting.
doi:10.2344/12-00001.1
PMCID: PMC3468288  PMID: 23050750
Propofol; Ketamine; Remifentanil; Deep sedation; TIVA
6.  The Use of Propofol as a Sedative Agent in Gastrointestinal Endoscopy: A Meta-Analysis 
PLoS ONE  2013;8(1):e53311.
Objectives
To assess the efficacy and safety of propofol sedation for gastrointestinal endoscopy, we conducted a meta-analysis of randomized controlled trials (RCTs) comparing propofol with traditional sedative agents.
Methods
RCTs comparing the effects of propofol and traditional sedative agents during gastrointestinal endoscopy were found on MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE. Cardiopulmonary complications (i.e., hypoxia, hypotension, arrhythmia, and apnea) and sedation profiles were assessed.
Results
Twenty-two original RCTs investigating a total of 1,798 patients, of whom 912 received propofol only and 886 received traditional sedative agents only, met the inclusion criteria. Propofol use was associated with shorter recovery (13 studies, 1,165 patients; WMD –19.75; 95% CI –27.65, 11.86) and discharge times (seven studies, 471 patients; WMD –29.48; 95% CI –44.13, –14.83), higher post-anesthesia recovery scores (four studies, 503 patients; WMD 2.03; 95% CI 1.59, 2.46), better sedation (nine studies, 592 patients; OR 4.78; 95% CI 2.56, 8.93), and greater patient cooperation (six studies, 709 patients; WMD 1.27; 95% CI 0.53, 2.02), as well as more local pain on injection (six studies, 547 patients; OR 10.19; 95% CI 3.93, 26.39). Effects of propofol on cardiopulmonary complications, procedure duration, amnesia, pain during endoscopy, and patient satisfaction were not found to be significantly different from those of traditional sedative agents.
Conclusions
Propofol is safe and effective for gastrointestinal endoscopy procedures and is associated with shorter recovery and discharge periods, higher post-anesthesia recovery scores, better sedation, and greater patient cooperation than traditional sedation, without an increase in cardiopulmonary complications. Care should be taken when extrapolating our results to specific practice settings and high-risk patient subgroups.
doi:10.1371/journal.pone.0053311
PMCID: PMC3540096  PMID: 23308191
7.  Propofol for procedural sedation in the emergency department 
Emergency Medicine Journal : EMJ  2007;24(7):459-461.
Objectives
To observe procedural sedation practice within a district general hospital emergency department (ED) that uses propofol for procedural sedation.
Methods
Prospective observation of procedural sedation over an 11 month period. Patients over 16 years of age requiring procedural sedation and able to give informed consent were recruited. The choice of sedation agent was at the discretion of the physician. The following details were recorded on a standard proforma for each patient: indication for procedural sedation; agent used; depth and duration of sedation; ease of reduction; use of a reversal agent; complications and reasons for delayed discharge from the ED.
Results
48 patients were recruited; propofol was used in 32 cases and midazolam in 16 cases. The median period of sedation was considerably shorter in the propofol group (3 vs 45 min) but this did not confer a shorter median time in the ED (200 vs 175 min). There were no documented cases of over‐sedation in the propofol group; however, four patients in the midazolam group were over‐sedated, three requiring reversal with flumazenil. There were no other significant complications in either group. There was no difference in the median depth of sedation achieved or ease of reduction between the two groups.
Conclusions
Propofol is effective and safe for procedural sedation in the ED. Propofol has a considerably shorter duration of action than midazolam, thereby shortening the period of sedation.
doi:10.1136/emj.2007.046714
PMCID: PMC2658387  PMID: 17582032
8.  Intravenous ketamine plus midazolam is superior to intranasal midazolam for emergency paediatric procedural sedation 
Objectives—This study compared intranasal midazolam (INM) with a combination of intravenous ketamine and intravenous midazolam (IVKM) for sedation of children requiring minor procedures in the emergency department.
Method—A single blinded randomised clinical trial was conducted in the emergency department of a major urban paediatric hospital. Subjects requiring sedation for minor procedures were randomised to receive either INM (0.4 mg/kg) or intravenous ketamine (1 mg/kg) plus intravenous midazolam (0.1 mg/kg). Physiological variables and two independent measures of sedation (Sedation Score and Visual Analogue Sedation Scale) were recorded before sedation and at regular intervals during the procedure and recovery period. Times to adequate level of sedation and to discharge were compared.
Results—Fifty three patients were enrolled over a 10 month period. Sedation was sufficient to complete the procedures in all children receiving IVKM and in 24 of the 26 receiving INM. Onset of sedation was an average of 5.3 minutes quicker with IVKM than with INM (95%CI 3.2, 7.4 minutes, p<0.001). Children given INM were discharged an average of 19 minutes earlier than those given IVKM (95%CI 4, 33 minutes, p=0.02). Mean Sedation Scores and Visual Analogue Sedation Scale scores for the 30 minutes after drug administration were significantly better in children given IVKM compared with INM (2.4 and 1.8 versus 3.5 and 3.8, respectively). Both doctors and parents were more satisfied with sedation by intravenous ketamine and midazolam.
Conclusions—Intravenous ketamine plus midazolam used in an appropriate setting by experienced personnel provides an excellent means of achieving sedation suitable for most non-painful minor procedures for children in the emergency department. This combination is superior to INM in terms of speed of onset and consistency of effect. INM delivered via aerosol spray has a more variable effect but may still be adequate for the completion of many of these procedures.
doi:10.1136/emj.18.1.39
PMCID: PMC1725505  PMID: 11310461
9.  Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care 
Critical Care  2000;4(5):302-308.
The respiratory effects of dexmedetomidine were retrospectively examined in 33 postsurgical patients involved in a randomised, placebo-controlled trial after extubation in the intensive care unit (ICU). Morphine requirements were reduced by over 50% in patients receiving dexmedetomidine. There were no differences in respiratory rates, oxygen saturations, arterial pH and arterial partial carbon dioxide tension (PaCO2) between the groups. Interestingly the arterial partial oxygen tension (PaO2) : fractional inspired oxygen (FIO2) ratios were statistically significantly higher in the dexmedetomidine group. Dexmedetomidine provides important postsurgical analgesia and appears to have no clinically important adverse effects on respiration in the surgical patient who requires intensive care.
Introduction:
The α2-agonist dexmedetomidine is a new class of sedative drug that is being investigated for use in ICU settings. It is an effective agent for the management of sedation and analgesia after cardiac, general, orthopaedic, head and neck, oncological and vascular surgery in the ICU [1]. Cardiovascular stability was demonstrated, with significant reductions in rate-pressure product during sedation and over the extubation period.
Dexmedetomidine possesses several properties that may additionally benefit those critically ill patients who require sedation. In spontaneously breathing volunteers, intravenous dexmedetomidine caused marked sedation with only mild reductions in resting ventilation at higher doses [2]. Dexmedetomidine reduces the haemodynamic response to intubation and extubation [3,4,5] and attenuates the stress response to surgery [6], as a result of the α2-mediated reduction in sympathetic tone. Therefore, it should be possible to continue sedation with dexmedetomidine over the stressful extubation period without concerns over respiratory depression, while ensuring that haemodynamic stability is preserved.
The present study is a retrospective analysis of the respiratory response to dexmedetomidine in 33 postsurgical patients (who were involved in a randomized, double-blind, placebo-controlled trial [1]) after extubation in the ICU.
Methods:
Patients who participated in the present study were admitted after surgery to our general or cardiothoracic ICUs, and were expected to receive at least 6 h of postsurgical sedation and artificial ventilation.
On arrival in the ICU after surgery, patients were randomized to receive either dexmedetomidine or placebo (normal saline) with rescue sedation and analgesia being provided, only if clinically needed, with midazolam and morphine boluses, respectively. Sedation was titrated to maintain a Ramsay Sedation Score [7] of 3 or greater while the patients were intubated, and infusions of study drug were continued for a maximum of 6 h after extubation to achieve a Ramsay Sedation Score of 2 or greater.
The patients were intubated and ventilated with oxygen-enriched air to attain acceptable arterial blood gases, and extubation occurred when clinically indicated. All patients received supplemental oxygen after extubation, which was delivered by a fixed performance device. Assessment of pain was by direct communication with the patient.
Results are expressed as mean ± standard deviation unless otherwise stated. Patient characteristics, operative details and morphine usage were analyzed using the Mann-Whitney U-test. Statistical differences for respiratory measurements between the two groups were determined using analysis of variance for repeated measures, with the Bonferroni test for post hoc comparisons.
Results:
Of the 40 patients who participated in the study, seven patients could not be included in the analysis of respiratory function because they did not receive a study drug infusion after extubation. Consequently, data from 33 patients are used in the analysis of respiratory function; 16 received dexmedetomidine and 17 placebo. Inadequate arterial blood gas analysis was available in five patients (two from the dexmedetomidine group, and three from the placebo group). There were no significant differences in patient characteristics and operative details between the groups.
Requirements for morphine were reduced by more than 50% in patients receiving dexmedetomidine when compared with placebo after extubation (0.003 ± 0.004 vs 0.008 ± 0.006 mg/kg per h; P= 0.040).
There were no statistically significant differences between placebo and dexmedetomidine for oxygen saturations measured by pulse oximetry (P= 0.26), respiratory rate (P= 0.16; Fig. 1), arterial pH (P= 0.77) and PaCO2 (P= 0.75; Fig. 2) for the 6 h after extubation.
The dexmedetomidine group showed significantly higher PaO2: FIO2 ratios throughout the 6-h intubation (P= 0.036) and extubation (P= 0.037) periods (Fig. 3). There were no adverse respiratory events seen in either the dexmedetomidine or placebo group.
Respiratory rate for the 6-h periods before and after extubation. (Filled circle) Dexmedetomidine; (Empty circle) placebo. Values are expressed as mean ± standard deviation.
PaCO2 (PCO2) for the 6-h periods before and after extubation, and baseline values (B) on admission to ICU immediately after surgery. (Filled circle) Dexmedetomidine; (Empty circle) placebo. Values are expressed as mean ± standard deviation.
PaO2 : FIO2 ratio for the 6-h periods before and after extubation, and baseline values (B) on admission to ICU immediately after surgery. (Filled circle) Dexmedetomidine; (Empty circle) placebo. Values are expressed as mean ± standard deviation.
Discussion:
Lack of respiratory depression in patients sedated with α2-adrenoceptor agonists was first reported by Maxwell [8] in a study investigating the respiratory effects of clonidine. However, more recent data suggests that clonidine may cause mild respiratory depression in humans [9], and α2-adrenoceptor agonists are well known to produce profound intraoperative hypoxaemia in sheep [10,11]. The effects of dexmedetomidine on other ventilation parameters also appear to be species specific [12].
Belleville et al [2] investigated the ventilatory effects of a 2-min intravenous infusion of dexmedetomidine on human volunteers. According to those investigators, minute ventilation and arterial PaCO2 were mildly decreased and increased, respectively. There was a rightward shift and depression of the hypercapnic response with infusions of 1.0 and 2.0 μg/kg.
Previous studies that investigated the respiratory effects of dexmedetomidine have only been performed in healthy human volunteers, who have received either single intramuscular injections or short (= 10 min) intravenous infusions of dexmedetomidine. It is therefore reassuring that no deleterious clinical effects on respiration and gas exchange were seen in the patients we studied, who were receiving long-term infusions. However, there are important limitations to the present results. No dose/response curve for dexmedetomidine can be formulated from the data, and further investigation is probably ethically difficult to achieve in the spontaneously ventilating intensive care patient. We also have no data on the ventilatory responses to hypercapnia and hypoxia, which would also be difficult to examine practically and ethically. The placebo group received more than twice as much morphine as patients receiving dexmedetomidine infusions after extubation, but there were no differences in respiratory rate or PaCO2 between the groups. We can not therefore determine from this study whether dexmedetomidine has any benefits over morphine from a respiratory perspective.
There were no differences in oxygen saturations between the groups because the administered oxygen concentration was adjusted to maintain satisfactory gas exchange. Interestingly, however, there were statistically significant higher PaO2 : FIO2 ratios in the dexmedetomidine group. This ratio allows for the variation in administered oxygen to patients during the study period, and gives some clinical indication of alveolar gas exchange. However, this variable was not a primary outcome variable for the present study, and may represent a type 1 error, although post hoc analysis reveals that the data have 80% power to detect a significant difference (α value 0.05). Further studies are obviously required.
Sedation continued over the extubation period, has been shown to reduce haemodynamic disturbances and myocardial ischaemia [13]. We have previously shown [1] that dexmedetomidine provides cardiovascular stability, with a reduction in rate-pressure product over the extubation period. A sedative agent that has analgesic properties, minimal effects on respiration and offers ischaemia protection would have enormous potential in the ICU. Dexmedetomidine may fulfill all of these roles, but at present we can only conclude that dexmedetomidine has no deleterious clinical effects on respiration when used in doses that are sufficient to provide adequate sedation and effective analgesia in the surgical population requiring intensive care.
PMCID: PMC29047  PMID: 11056756
α2-Adrenoceptor agonist; analgesia; dexmedetomidine; intensive care; postoperative; respiratory; sedation
10.  Retrospective Outcomes Evaluation of 100 Parenteral Moderate and Deep Sedations Conducted in a General Practice Dental Residency 
Anesthesia Progress  2008;55(4):116-120.
An abstract of this study was presented at the American Association for Dental Research (AADR) Dental Anesthesiology Research Group in Honolulu, Hawaii, in March of 2004. This study was conducted to correlate the intraoperative and postoperative morbidity associated with moderate and deep sedation, also known as monitored anesthesia care (MAC), provided in a General Practice Residency (GPR) clinic under the supervision of a dentist anesthesiologist. After internal review board approval was obtained, 100 parenteral moderate and deep sedation cases performed by the same dentist anesthesiologist in collaboration with second year GPR residents were randomly selected and reviewed by 2 independent evaluators. Eleven morbidity criteria were assessed and were correlated with patient age, gender, American Society of Anesthesiology Physical Status Classification (ASAPS), duration of procedure, and anesthetic protocol. A total of 39 males and 61 females were evaluated. Patients' ASAPS were classified as I, II, and III, with the average ASAPS of 1.61 and the standard deviation (STDEV) of 0.584. No ASPS IV or V was noted. Average patient age was 33.8 years (STDEV, 14.57), and the average duration of procedure was 97.5 minutes (STDEV, 42.39). Three incidents of postoperative nausea and vomiting were reported. All 3 incidents involved the ketamine-midazolam-propofol anesthetic combination. All patients were treated and were well controlled with ondansetron. One incident of tongue biting in an autistic child was regarded as an effect of local anesthesia. One patient demonstrated intermittent premature atrial contractions (PACs) intraoperatively but was stable. Moderate and deep sedation, also known as MAC, is safe and beneficial in an outpatient GPR setting with proper personnel and monitoring. This study did not demonstrate a correlation between length of procedure and morbidity. Ketamine was associated with all reported nausea and vomiting incidents because propofol and midazolam are rarely associated with such events.
doi:10.2344/0003-3006-55.4.116
PMCID: PMC2614649  PMID: 19108595
Dental sedation; Sedation training; Sedation outcomes
11.  Comparison of Procedural Sedation for the Reduction of Dislocated Total Hip Arthroplasty 
Introduction: Various types of sedation can be used for the reduction of a dislocated total hip arthroplasty. Traditionally, an opiate/benzodiazepine combination has been employed. The use of other pharmacologic agents, such as etomidate and propofol, have more recently gained popularity. Currently no studies directly comparing these sedation agents have been carried out. The purpose of this study is to compare differences in reduction and sedation outcomes, including recovery times, of these 3 sedation agents.
Methods: We performed a retrospective chart review examining 198 patients who presented with dislocated total hip arthroplasty at 2 academic affiliated medical centers. The patients were grouped according to the type of sedation agent. We calculated percentages of reduction and sedation complications along with recovery times. Reduction complications included fracture, skin or neurovascular injury, and failure of reduction requiring general anesthesia. Sedation complications included use of bag-valve mask and artificial airway, intubation, prolonged recovery, use of a reversal agent, and inability to achieve sedation. We then compared the data for each sedation agent.
Results: We found reduction complications rates of 8.7% in the propofol, 24.7% in the etomidate, and 28.9% in the opiate/benzodiazepine groups. The propofol group was significantly different from the other 2agents (p ≤ 0.01). Sedation complications were found 7.3% of the time in the propofol , 11.7% in the etomidate , and 21.3% in the opiate/benzodiazepine group, (p=0.02 propofol vs. others) . Average recovery times were 25.2 minutes for propofol, 30.8 minutes for etomidate, and 44.4 minutes for opiate/benzodiazepine (p = 0.05 for propofol vs. other agents).
Conclusion: For reduction of dislocated total hip arthroplasty under procedural sedation, propofol appears to have fewer complications and a trend toward more rapid recovery than both etomidate and opiate/benzodiazepine. These data support the use of propofol as first line agent for procedural sedation of dislocated total hip arthroplasty, with fewer complications and a shorter recovery period.
doi:10.5811/westjem.2013.7.15616
PMCID: PMC3952894  PMID: 24696752
12.  The use of anaesthetic agents to provide anxiolysis and sedation in dentistry and oral surgery 
The Australasian Medical Journal  2013;6(12):713-718.
Throughout the world there is considerable variation in the techniques used to manage anxious dental patients requiring treatment. Traditionally anxious or phobic dental patients may have been sent for general anaesthesia to allow dental treatment be undertaken. While this is still the case for the more invasive oral surgical procedures, such as wisdom teeth extraction, sedation in general dentistry is becoming more popular.
Various sedation techniques using many different anaesthetic agents have gained considerable popularity over the past 30 years. While the practice of sedating patients for dental procedures is invaluable in the management of suitably assessed patients, patient safety must always be the primary concern. Medical, dental and psychosocial considerations must be taken into account when evaluating the patient need and the patient suitability for sedation or general anaesthesia.
The regulations that govern the practice of dental sedation vary throughout the world, in particular regarding the techniques used and the training necessary for dental practitioners to sedate patients. It is necessary for medical and dental practitioners to be up to date on current practice to ensure standards of practice, competence and safety throughout our profession.
This article, the first in a two-part series, will provide information to practitioners on the practice of sedation in dentistry, the circumstances where it may be appropriate instead of general anaesthesia and the risks involved with sedation. It will also discuss the specific training and qualifications required for dental practitioners to provide sedation. The second article in this series will outline the different techniques used to administer inhalation, oral and intravenous sedation in dentistry and will focus on specific methods that are practiced.
doi:10.4066/AMJ.2013.1836
PMCID: PMC3877855  PMID: 24391684
Conscious sedation; sedation; dentistry; anaesthetic agents; fear; dental phobia; anxiolysis; access to treatment
13.  An Evaluation of Intranasal Sufentanil and Dexmedetomidine for Pediatric Dental Sedation 
Pharmaceutics  2014;6(1):175-184.
Conscious or moderate sedation is routinely used to facilitate the dental care of the pre- or un-cooperative child. Dexmedetomidine (DEX) has little respiratory depressant effect, possibly making it a safer option when used as an adjunct to either opioids or benzodiazepines. Unlike intranasal (IN) midazolam, IN application of DEX and sufentanil (SUF) does not appear to cause much discomfort. Further, although DEX lacks respiratory depressive effects, it is an α2-agonist that can cause hypotension and bradycardia when given in high doses or during prolonged periods of administration. The aim of this feasibility study was to prospectively assess IN DEX/SUF as a potential sedation regimen for pediatric dental procedures. After IRB approval and informed consent, children (aged 3–7 years; n = 20) from our dental clinic were recruited. All patients received 2 μg/kg (max 40 μg) of IN DEX 45 min before the procedure, followed 30 min later by 1 μg/kg (max 20 μg) of IN SUF. An independent observer rated the effects of sedation using the Ohio State University Behavior Rating Scale (OSUBRS) and University of Michigan Sedation Scale (UMSS). The dentist and the parent also assessed the efficacy of sedation. Dental procedures were well tolerated and none were aborted. The mean OSUBRS procedure score was 2.1, the UMSS procedure score was 1.6, and all scores returned to baseline after the procedure. The average dentist rated quality of sedation was 7.6 across the 20 subjects. After discharge, parents reported one child with prolonged drowsiness and one child who vomited at home. The use of IN DEX supplemented with IN SUF provided both an effective and tolerable form of moderate sedation. Although onset and recovery are slower than with oral (PO) midazolam and transmucosal fentanyl, the quality of the sedation may be better with less risk of respiratory depression. Results from this preliminary study showed no major complications from IN delivery of these agents.
doi:10.3390/pharmaceutics6010175
PMCID: PMC3978530  PMID: 24662315
pediatric sedation; pediatric dentistry; intranasal drug administration
14.  Trends in Death Associated with Pediatric Dental Sedation and General Anesthesia 
Paediatric anaesthesia  2013;23(8):741-746.
Background
Inadequate access to oral health care places children at risk for caries. Disease severity and inability to cooperate often result in treatment with general anesthesia (GA). Sedation is increasingly popular and viewed as lower risk than GA in community settings. Currently, few data are available to quantify pediatric morbidity and mortality related to dental anesthesia.
Objective
Summarize dental anesthesia-related pediatric deaths described in media reports.
Methods
Review of media reports in the Lexis-Nexis Academic database and a private foundation website.
Settings
Dental offices, ambulatory surgery centers, and hospitals.
Patients
U.S.-based children (≤ 21 y.o.) who died subsequent to receiving anesthesia for a dental procedure between 1980–2011.
Results
Most deaths occurred among 2 –5 year-olds (n=21/44); in an office setting (n=21/44), and with a general/pediatric dentist (n=25/44) as the anesthesia provider. In this latter group, 17/25 deaths were linked with a sedation anesthetic.
Conclusions
This series of media reports likely represent only a fraction of the overall morbidity and mortality related to dental anesthesia. These data may indicate an association between mortality and pediatric dental procedures under sedation, particularly in office settings. However, these relationships are difficult to test in the absence of a database that could provide an estimate of incidence and prevalence of morbidity and mortality. With growing numbers of children receiving anesthesia for dental procedures from providers with variable training, it is imperative to be able to track anesthesia-related adverse outcomes. Creating a national database of adverse outcomes will enable future research to advance patient safety and quality.
doi:10.1111/pan.12210
PMCID: PMC3712625  PMID: 23763673
Anesthesia; Patient safety; Child; Conscious Sedation/adverse effects; Dental Anxiety/drug therapy; Treatment Outcome
15.  Impact of the United States propofol ban on emergency providers’ procedural sedation agent choice and patient length of stay 
BACKGROUND:
In the recent past, propofol was temporarily removed from the emergency department (ED) for use in procedural sedation. We sought to determine which agents replaced it in clinical practice and the impact this change had on turnaround times (TAT) for sedated patients.
METHODS:
This study is a retrospective chart review at a level one trauma center. Patients receiving sedative agents (propofol, ketamine, midazolam, and etomidate) were identified by pharmacy codes, and their charts were then reviewed for demographics and TAT. Propofol was unavailable in the emergency department (ED) between May 2010 and February 2011. The study period extended from May 2009 until May 2011. Patients receiving sedation by non-emergency medicine physicians and those receiving sedation related to intubation were excluded.
RESULTS:
In total 2466 charts were reviewed and 209 met inclusion criteria. When propofol was available, the most commonly used sedative agent was etomidate (40%), followed by propofol (28%), ketamine (20%), and midazolam (6%). When propofol was unavailable, etomidate remained the most commonly used agent (43%), followed by ketamine (41%), and midazolam (11%). When propofol was available, the median TAT for sedated patients was 163 minutes compared to 178 minutes when propofol was unavailable (P=0.83). When propofol was the primary sedative agent used, the median TAT was 166 minutes as compared with a median TAT of 172 minutes for all other sedative agents combined (P=0.87).
CONCLUSION:
When propofol was unavailable, ketamine became a preferred ED sedation agent. Removal of propofol from the sedation armamentarium did not affect ED TAT.
doi:10.5847/wjem.j.issn.1920-8642.2012.03.003
PMCID: PMC4129780  PMID: 25215059
Procedural sedation; Turnaround time; Propofol; Ketamine; Etomidate; Midazolam
16.  A Comparison of Fospropofol to Midazolam for Moderate Sedation During Outpatient Dental Procedures 
Anesthesia Progress  2013;60(4):162-177.
Moderate intravenous (IV) sedation combined with local anesthesia is common for outpatient oral surgery procedures. An ideal sedative agent must be safe and well tolerated by patients and practitioners. This study evaluated fospropofol, a relatively new sedative/hypnotic, in comparison to midazolam, a commonly used benzodiazepine, for IV moderate sedation during oral and maxillofacial surgery. Sixty patients were randomly assigned to either the fospropofol or the midazolam group. Each participant received 1 μg/kg of fentanyl prior to administration of the selected sedative. Those in the fospropofol group received an initial dose of 6.5 mg/kg, with 1.6 mg/kg supplemental doses as needed. Those in the midazolam group received initial doses of 0.05 mg/kg, followed by 0.02 mg/kg supplemental doses. The quality of sedation in each patient was evaluated with regard to (a) onset of sedation, maintenance, and recovery profile; (b) patient and surgeon satisfaction; and (c) hemodynamic stability and adverse effects. The fospropofol group demonstrated shorter physical recovery times than midazolam patients, taking a mean of 11.6 minutes versus 18.4 minutes for physical recovery (P = .007). Cognitive recovery comparison did not find any difference with a mean of 7.5 minutes versus 8.8 minutes between the 2 drug groups (P = .123). The fospropofol group had a higher rate of local anesthetic injection recall (90.5 vs 44.4%, P = .004). Other parameters of recall were comparable. Two adverse effects demonstrated significance, with more patients in the midazolam group experiencing tachycardia (48.2 vs 9.4%, P = .001), and more patients in the fospropofol group experiencing perineal discomfort (40.6 vs 0, P < .001). No significant difference was found in any other measures of sedation safety, maintenance, or satisfaction. Fospropofol, when administered intravenously by a dentist anesthesiologist at the indicated dose in this study, appears to be a safe, well-tolerated alternative to midazolam for intravenous moderate sedation during minor oral surgery procedures.
doi:10.2344/0003-3006-60.4.162
PMCID: PMC3891457  PMID: 24423419
Fospropofol; Midazolam; Moderate sedation; Outpatient surgery; IV conscious sedation; Benzodiazepine; Propofol
17.  Post-sedation Events in Children Sedated for Dental Care 
Anesthesia Progress  2013;60(2):54-59.
Moderate oral sedation is used in pediatric dentistry for safe delivery of dental care to children. However, there is a paucity of data on the effects of pediatric dental sedations after discharge of children from the dental office. The purpose of this study was to evaluate and compare the incidence of adverse events occurring with meperidine and hydroxyzine versus midazolam alone 8 and 24 hours after sedation in pediatric dental patients. In this prospective study, a convenience sample of 46 healthy children presenting to a private pediatric dental practice for dental treatment needs was selected. A telephone survey of the parents of children sedated with either meperidine and hydroxyzine or midazolam alone was conducted 8 and 24 hours after the administration of sedation medications. Data analysis included descriptive statistics, frequency and proportion analysis, and Fisher exact test. Forty children were sedated with meperidine and hydroxyzine, and 6 who were sedated with midazolam. In both groups, 50% of the children slept in the car on the way home. Three children in the meperidine and hydroxyzine group vomited in the car. A significantly larger proportion of children in the meperidine and hydroxyzine group experienced prolonged sleep at home (P = .015). More children in the midazolam group exhibited irritability in the first 8 hours (P = .07). There were no statistical differences between the 2 groups with respect to incidence of pain, fever, vomiting, sleeping in the car, snoring, and difficulty in waking up. The lingering effects of orally administered sedation medications can lead to prolonged sleep, irritability, and vomiting in children after they have been discharged from the dental clinic. Most of these events occurred within the first 8 hours, but in some children the effects were seen up to 24 hours later.
doi:10.2344/0003-3006-60.2.54
PMCID: PMC3683881  PMID: 23763560
Sedation; Children; Adverse events
18.  Propofol versus Midazolam for Sedation during Esophagogastroduodenoscopy in Children 
Clinical Endoscopy  2013;46(4):368-372.
Background/Aims
To evaluate the efficacy and safety of propofol and midazolam for sedation during esophagogastroduodenoscopy (EGD) in children.
Methods
We retrospectively reviewed the hospital records of 62 children who underwent ambulatory diagnostic EGD during 1-year period. Data were collected from 34 consecutive patients receiving propofol alone. Twenty-eight consecutive patients who received sedation with midazolam served as a comparison group. Outcome variables were length of procedure, time to recovery and need for additional supportive measures.
Results
There were no statistically significant differences between the two groups in age, weight, sex, and the length of endoscopic procedure. The recovery time from sedation was markedly shorter in propofol group (30±16.41 minutes) compared with midazolam group (58.89±17.32 minutes; p<0.0001). During and after the procedure the mean heart rate was increased in midazolam group (133.04±19.92 and 97.82±16.7) compared with propofol group (110.26±20.14 and 83.26±12.33; p<0.0001). There was no localized pain during sedative administration in midazolam group, though six patients had localized pain during administration of propofol (p<0.028). There was no serious major complication associated with any of the 62 procedures.
Conclusions
Intravenous administered propofol provides faster recovery time and similarly safe sedation compared with midazolam in pediatric patients undergoing upper gastrointestinal endoscopy.
doi:10.5946/ce.2013.46.4.368
PMCID: PMC3746141  PMID: 23964333
Propofol; Midazolam; Endoscopy, digestive system; Child
19.  Conscious Sedation and Emergency Department Length of Stay: A Comparison of Propofol, Ketamine, and Fentanyl/Versed 
Study Objectives:
Three of the most commonly used agents for conscious sedation in the Emergency Department (ED) are ketamine, fentanyl/versed, and propofol. In this study, we measured and compared the total times spent in the ED with each of these agents. Our objective was to determine whether the use of propofol for conscious sedation was associated with a shorter length of ED stay as compared to the other two agents.
Methods:
This was a consecutive case series. All patients who required procedural conscious sedation who presented to the ED at University of California, Irvine Medical Center from January 2003 through April 2004 were included in the study. The attending ED physician evaluated the patient and determined which medication(s) would be administered. All patients underwent procedural sedation according to the ED’s standardized sedation protocol. The times and dosages of administered medications and the sedation/consciousness level (SCL) scores were recorded by ED nurses at 3–5 minute intervals. Data was abstracted prospectively. The time to sedation (first dose of agent to SCL score of 2 or less) and time to recovery (last dose of agent to SCL score of 4) of the different regimens were then analyzed and compared.
Results:
Thirty-eight patients received propofol, 38 received ketamine, and 14 received fentanyl/versed. The mean times to sedation (minutes) were: propofol 4.5 (95% CI: 3.3–5.7), ketamine 10.6 (95% CI: 5.8–15.4), fentanyl/versed 11.5 (95% CI: 3.5–19.4). The mean times to recovery were: propofol 21.6 (95% CI: 16.1–27.1), ketamine 55.4 (95% CI: 46.2–64.5), fentanyl/versed 59.9 (95% CI: 20.3–99.5). Propofol had a statistically significant shorter time to sedation than both ketamine (p<.001) and fentanyl/versed (p=.022). Propofol also produced shorter recovery times than both ketamine (p<.001) and fentanyl/versed (p=.002).
Conclusion:
In this study, sedation and recovery times were shorter with propofol than with ketamine or fentanyl/versed. The use of propofol for conscious sedation in this non-randomized study was associated with a shorter ED length of stay.
PMCID: PMC2872520  PMID: 20505814
20.  Pain assessment during conscious sedation for cervical cancer high-dose-rate brachytherapy 
Current Oncology  2013;20(4):e307-e310.
Background
This observational study set out to evaluate the effectiveness of conscious sedation anesthesia for pain control during high-dose-rate (hdr) brachytherapy using a ring-and-tandem applicator system for patients with cervical cancer.
Methods
At the time of initiation of the hdr cervical cancer brachytherapy program at our institution, patients received a detailed symptom assessment during the procedures. Brachytherapy was carried out using a Smit sleeve, together with a ring-and-tandem applicator. Midazolam and an opioid—hydromorphone, morphine, or fentanyl—were the main agents used to achieve conscious sedation.
Results
From January 2009 to October 2010, 20 patients (median age: 45 years) underwent 57 procedures. All patients received chemoradiation with curative intent. The median duration of the procedures was 1.4 hours, and no significant cardiovascular events were noted. The total dose of intravenous midazolam used ranged from 0.5 mg to 8.5 mg (median: 2.5 mg). The total dose of intravenous morphine equivalent used ranged from 2.5 mg to 60 mg (median: 8 mg). The mean and median pain scores during the procedures were 1.4 and 1.1 respectively. Brief moments of moderate to severe incidental pain were noted at the time of certain events during the procedure—specifically during insertion of the ring-and-tandem applicator. The maximal pain score during the entire procedure ranged from 0 to 10 (median: 4.7). The period of recovery from conscious sedation was relatively brief (median discharge time: 1 hour).
Conclusions
We were able to demonstrate that patients undergoing hdr brachytherapy for cervical cancer can achieve good pain control with conscious sedation.
doi:10.3747/co.20.1404
PMCID: PMC3728059  PMID: 23904769
Cervical cancer; carcinoma of the cervix; conscious sedation; high-dose-rate brachytherapy; pain and symptom assessment; incidental pain; recovery time
21.  Clinical Effectiveness of an Anesthesiologist-Administered Intravenous Sedation Outside of the Main Operating Room for Pediatric Upper Gastrointestinal Endoscopy in Thailand 
Objectives. To review our sedation practice and to evaluate the clinical effectiveness of an anesthesiologist-administered intravenous sedation outside of the main operating room for pediatric upper gastrointestinal endoscopy (UGIE) in Thailand. Subjects and Methods. We undertook a retrospective review of the sedation service records of pediatric patients who underwent UGIE. All endoscopies were performed by a pediatric gastroenterologist. All sedation was administered by staff anesthesiologist or anesthetic personnel. Results. A total of 168 patients (94 boys and 74 girls), with age from 4 months to 12 years, underwent 176 UGIE procedures. Of these, 142 UGIE procedures were performed with intravenous sedation (IVS). The mean sedation time was 23.2 ± 10.0 minutes. Propofol was the most common sedative drugs used. Mean dose of propofol, midazolam and fentanyl was 10.0 ± 7.5 mg/kg/hr, 0.2 ± 0.2 mg/kg/hr, and 2.5 ± 1.2 mcg/kg/hr, respectively. Complications relatively occurred frequently. All sedations were successful. However, two patients became more deeply than intended and required unplanned endotracheal intubation. Conclusion. The study shows the clinical effectiveness of an anesthesiologist-administered IVS outside of the main operating room for pediatric UGIE in Thailand. All complications are relatively high. We recommend the use of more sensitive equipments such as end tidal CO2 and carefully select more appropriate patients.
doi:10.1155/2010/748564
PMCID: PMC2929513  PMID: 20811603
22.  Comparative evaluation of recovery characteristics of fentanyl and butorphanol when used as supplement to propofol anaesthesia 
Background and Aim:
Narcotics have been used since long as a component of balanced anaesthesia, thus minimizing the anaesthetic requirement both during induction and maintenance as well as attenuating the pressor response during laryngoscopy and intubation. Equally significant is their role in provision of smoother recovery period by minimizing postoperative pain. Other than pain, the factors like postoperative nausea and vomiting (PONV), shivering, sedation and respiratory depression are equally important in recovery from the effects of anaesthetic drugs. The present study aimed at comparing the postoperative recovery characterstics of fentanyl and butorphanol in patients undergoing open cholecystectomy under general anaesthesia.
Materials and Methods:
The present study configured one hundred adults patients of American Society of Anaesthesiologists (ASA) grade 1 or 2 of either sex scheduled to undergo elective open cholecystectomy and were randomly assigned to receive fentanyl (group F; n = 50) or butorphanol (group B; n = 50). Both group were premedicated with midazolam 0.04 mg/kg intravenously followed by injection fentanyl 2 mcg/kg or butorphanol 40 mcg/kg. Standard induction was done with propofol 2 mg/kg and vecuronium 0.1 mg/kg was used for intubation. Anaesthesia was maintained with propofol infusion and 67% nitrous oxide in oxygen. Intraoperative hemodynamic parameters were observed and recorded. Postoperatively analgesia, sedation, PONV, shivering, respiratory depression and recovery score were observed.
Results:
The recovery time was less in group F (P > 0.05) while post operative analgesia (P < 0.001) and sedation (P > 0.05) was more in group B. The incidence of respiratory depression was more in group B (P > 0.05). PONV was comparable in both the groups. Postoperative shivering was significantly low in group B (P < 0.05).
Conclusion:
It is concluded that besides easy availability and lower cost, butorphanol decreased propofol consumption intraoperatively and provided better analgesia and prophylaxis against shivering in postoperative period.
doi:10.4103/2229-516X.106350
PMCID: PMC3678702  PMID: 23776820
Butorphanol; fentanyl; propofol; recovery
23.  Sedative Efficacy of Propofol in Patients Intubated/Ventilated after Coronary Artery Bypass Graft Surgery 
Background:
Sedation after open heart surgery is important in preventing stress on the heart. The unique sedative features of propofol prompted us to evaluate its potential clinical role in the sedation of post-CABG patients.
Objectives:
To compare propofol-based sedation to midazolam-based sedation after coronary artery bypass graft (CABG) surgery in the intensive care unit (ICU).
Patients and Methods:
Fifty patients who were admitted to the ICU after CABG surgery was randomized into two groups to receive sedation with either midazolam or propofol infusions; and additional analgesia was administered if required. Inclusion criteria were as follows: patients 40-60 years old, hemodynamic stability, ejection fraction (EF) more than 40%; exclusion criteria included patients who required intra-aortic balloon pump or inotropic drugs post-bypass. The same protocol of anesthetic medications was used in both groups. Depth of sedation was monitored using the Ramsay sedation score (RSS). Invasive mean arterial pressure (MAP) and heart rate (HR), arterial blood gas (ABG) and ventilatory parameters were monitored continuously after the start of study drug and until the patients were extubated.
Results:
The depth of sedation was almost the same in the two groups (RSS=4.5 in midazolam group vs 4.7 in propofol group; P = 0.259) but the total dose of fentanyl in the midazolam group was significantly more than the propofol group (12.5 mg/hr vs 4 mg/hr) (P = 0.0039). No significant differences were found in MAP (P = 0.51) and HR (P = 0.41) between the groups. The mean extubation time in patients sedated with propofol was shorter than those sedated with midazolam (102 ± 27 min vs 245 ± 42 min, respectively; P < 0.05) but the ICU discharge time was not shorter (47.5 hr vs 36.3 hr, respectively; P = 0.24).
Conclusions:
Propofol provided a safe and acceptable sedation for post-CABG surgical patients, significantly reduced the requirement for analgesics, and allowed for more rapid tracheal extubation than midazolam but did not result in earlier ICU discharge.
doi:10.5812/aapm.17109
PMCID: PMC3961039  PMID: 24660162
Propofol; Analgesics; Coronary Artery Bypass; Deep Sedation; Midazolam; Airway Extubation; Length of Stay
24.  The impact of diphenhydramine and promethazine in patients undergoing advanced upper endoscopic procedures 
Background
Endoscopic retrograde cholangiopancreatography (ERCP ) and endoscopic ultrasound (EUS) procedures are more complex and longer duration than standard endoscopy, requiring deeper levels of sedation. While prior studies have compared standard sedation (meperidine and midazolam) to propofol, no randomized, controlled trials have evaluated the use of adjunct sedatives in these procedures.
Aims
To prospectively compare the use of promethazine and diphenhydramine as adjunct sedatives to standard sedation in patients undergoing advanced endoscopic procedures.
Methods
This was a prospective, randomized, placebo-controlled study in a single, tertiary-care referral center. Promethazine (P), diphenhydramine (B), or normal saline (NS) were given as adjunct sedatives along with meperidine and midazolam in adult patients undergoing upper EUS and/or ERCP procedures. The main outcome measurement was sedation failure.
Results
292 patients (P: 97, B: 93, NS: 102) were randomized over 36 months. No significant differences in sedation failures (P: 8, B: 13, NS: 11, p=0.449) or in the times needed to achieve adequate sedation (P: 11.8 minutes, B: 12.9 minutes, NS: 14.0 minutes, p=0.054) were seen between the groups. Sedation using P (43.7 minutes) was associated with a significantly longer recovery time compared to B (28.0 minutes) or NS (24.5 minutes).
Conclusions
The use of promethazine and diphenhydramine as adjunct sedatives did not improve sedation failure rates or reduce the time needed to achieve sedation in patients undergoing upper EUS or ERCP. Patients with anticipated sedation difficulties should proceed directly to propofol-based sedation.
doi:10.7178/jig.124
PMCID: PMC3896573  PMID: 24498528
promethazine; diphenhydramine; endoscopic retrograde cholangiopancreatography; endoscopic ultrasound; sedation
25.  Deep sedation during gastrointestinal endoscopy: Propofol-fentanyl and midazolam-fentanyl regimens 
AIM: To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy.
METHODS: After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer’s assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ2 test, measurement of analysis of variance, and the κ statistic.
RESULTS: The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination.
CONCLUSION: Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.
doi:10.3748/wjg.v19.i22.3439
PMCID: PMC3683682  PMID: 23801836
Endoscopy; Deep sedation; Anesthetic administration; Anesthetic dose; Adverse effects

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